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Clinical Study on Yiqi Kaimi Recipe Combined with Biofeedback in the Treatment of Functional Constipation with Rectal Hyposensitivity

Clinical Study on Yiqi Kaimi Recipe Combined with Biofeedback in the Treatment of Functional Constipation with Rectal Hyposensitivity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006103
Enrollment
Unknown
Registered
2022-06-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional constipation with rectal hyposensitivity

Interventions

Polyethylene glycol 4000:Polyethylene glycol 4000
Yiqi Kaimi Recipe:Yiqi Kaimi Recipe
Yiqi Kaimi Recipe + biofeedback:Yiqi Kaimi Recipe combined with biofeedback

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Diagnostic with functional constipation by Rome ?;and Diagnostic with low rectal sensitivity:Rectal sensation measurement: the minimum sensation threshold is more than 20ml, the initial defecation threshold is more than 60ml or the maximum tolerance threshold is more than 250ml, which meet one or more requirements. (2) syndrome with Qi and yin deficiency in traditional Chinese medicine; (3) Unlimited course of disease; (4) Patients aged from 18 to 80 (regardless of gender); (5) Patients who have signed informed consent. v

Exclusion criteria

Exclusion criteria: (1) Excluding those who do not meet the diagnostic criteria and inclusion criteria. (2) There are malignant intestinal lesions, or perianal acute infection and bleeding diseases. (3) There are serious diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and psychiatric patients. (4) diabetic patients with impaired glucose control (fasting blood glucose > 7.8mmol/L). (5) Patients with severe infection and critical condition. (6) Pregnant or lactating women, allergic constitution or abnormal liver function. (7) According to the judgment of the researcher, other medical histories that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, are easy to cause loss of follow-up. (8) Subjects participating in clinical studies of other drugs.

Design outcomes

Primary

MeasureTime frame
Cleveland clinic score, CCS;

Secondary

MeasureTime frame
Patient assessment of constipation quality of life;Patient assessment of constipation symptom, PAC-SYM; Gastrointestinal electromyography;Rectal sensation;Anorectal manometry;

Countries

China

Contacts

Public ContactWang Chen
wangchen_longhua@163.com+86 18917763340

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026